Les Jordan Joins Target Health as Vice President, Chief Product Evangelist


As part of Target Health’s commitment to the paperless clinical trial, we welcome Les Jordan to Target Health as Vice President and Chief Product Evangelist. Les’ mandate is to provide overall software product vision, architectural and technical guidance to our esteemed software development teams, and support for sales and marketing. Les brings to Target Health almost 20 years of Life Science industry experience and over 25 years of IT and IS management experience. His particular expertise includes systems that support clinical trials, and a passion for bringing patient engagement technologies to clinical trials.


Les spent 10 years as the CTO for Microsoft’s Life Sciences Industry Unit, where he was responsible for providing Life Science industry guidance to internal product teams particularly around regulatory compliance, and working with the largest Life Science companies on how to use Microsoft products to solve industry problems. He also served as Microsoft’s representative to industry standards groups, including CDISC, IHE and HL7.  After he left Microsoft, Les spent two years with Quintiles where he was responsible for sales and marketing for their IT Consulting Practice and 5 years with Webridge (now part of Huron Consulting) where he was responsible for launching their now market-leading suite of products into clinical trials and research compliance automation.


Les started his career at Boston Biostatistics (now part of Icon) as the IT Director and fourth employee, working with our good friend and colleague Dr. Phil Lavin. His responsibilities included the design and development of electronic data capture systems, installing client-server based clinical trials systems at many of the largest pharmaceutical and life sciences companies, and consulting with customers on the implementation of CANDA systems supporting drug filings to FDA.


Outside of pharmaceutical and life sciences companies, Les served six years in the financial services industry, with most of the time as an officer at State Street Bank, a Fortune 500 financial services firm, managing large IT projects and setting direction in the messaging and collaboration space. His efforts have resulted in invitations to speak at numerous conferences, events, and webinars on life science topics, as well as numerous interviews and articles published in publications including BioInform, ClinPage, Pharmaceutical Manufacturing, BioIT World, Applied Clinical Trials and Applied & Translational Genomics.


In his spare time, Les volunteers as a music teacher working with inner city children, designs web sites for local non-profits, and has served for almost 10 years as the Tournament Director for his local youth soccer association.


We are now setting up partnering meetings with large and small pharma companies, large and small CROs and independents to truly transform the industry. Our paperless and web-based solutions, with no need for any dedicated devices, include 1) direct data entry (eSource) at the time of the office visit, 2) integration with the electronic medical record (EMR), 3) electronic Informed Consent and 4) multiple clinical trial features, all at one website. Thus, the former, together with our expertise in drug and device development, and Target Health and 8 clinical sites passing FDA inspections of our software, and especially one FDA marketing approval, says it all.


No study is too small. We will pilot for those who just want to dip their toes in the water.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.


Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor



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Are Wearables Safe as They Alert Us to Our Present State of Health?


For those interested in some of the regulatory implications of wearables please see a paper we wrote for Applied Clinical Trialsthis year.


Greatly magnified, close-knit fabric, wired for wearable device. Source: Wikipedia Commons


Sometime over the last few years, wearable electronics have become the norm. Whether it’s a cell phone attached to a holster at the hip, a smart watch on the wrist, or sensors on and sometimes woven into clothing, these technologies are part of everyday life. Along with this trend, many of the devices are also now collecting and transmitting health information. That is certainly convenient, but the question with any kind of health care device, including wearable medical technology, has always been and continues to be: is it safe? With that in mind, experts are taking a hard look at new advances in medical-related wearable 1) ___and textiles to help ensure that while attempting to do good, the technology isn’t doing any harm, as some believe. In the US, the FDA is the primary regulatory agency overseeing wearable medical technology is the FDA which evaluates how well these devices and associated software applications do their jobs. The FDA issued its guidelines, Mobile Medical Applications Guidance for Industry and FDA Staff, in early 2015 to clarify its focus on wearable technologies with important medical implications. The document spells out the FDA’s emphasis on technologies that:


1. present “a greater risk to patients if they don’t work as intended.“ An app on a smartphone that monitors 2) ___ pressure for an individual who has a heart condition would fall under this description, whereas a device that a patient uses to record when he or she wants to light up a cigarette in a smoking cessation program would not.

2. impact “the functionality or performance of traditional medical devices,“ which would include new technologies that are designed to take the place of older medical technologies.


An electrocardiograph (ECG or EKG) is an example of the second focus. Early ECG machines were bulky instruments, but over time, they have been downsized to fit on a rollable cart and, more recently, onto hand-held devices. Today, smartphone-connected mobile apps are taking on the task of performing ECGs. Regardless of their format, all of these tools must perform similarly when it comes to capturing physiological data and performing the ECG-type functions.  FDA is looking at the functionality of the product as opposed to the platform of the technology or the size of the product. The FDA steps in and has an opinion when it doesn’t work as it’s intended. The FDA’s accentuation of functionality will remain constant into the future. According to FA, they want technology to evolve, but, at the same time, they want to be sure that we have very informed guiding principles so that people have a clear view of what we consider a medical device and when patient safety and public health are important. Accordingly, the FDA is continuing to hone its guidelines and add additional examples to reflect innovative technologies.


Wearable devices and textiles could potentially impact health on several fronts, including possible inaccuracies in the measurements they take, but exposure to electromagnetic 3) ___ is not an issue, according to Kenneth R. Foster, professor of bioengineering at the University of Pennsylvania. Foster feels that the U.S. Federal Communications Commission (FCC) also has some regulatory jurisdiction over wearable technologies, but, so far, its guidelines remain a bit behind the times. The FCC regulations were set up decades ago, when portable devices transmitted several watts of power, and it was necessary to keep them away from the body to ensure that FCC safety limits were maintained. He notes that the wearable devices today, however, operate at far lower power levels, but the regulations have not been updated. “This has led to strange situations, such as the instructions that came with my Pebble smart watch that say I should keep my watch 2.5 cm from my body.“ He speculates that a misunderstanding of FCC regulations may have led to the warning and notes that the warning has been removed from the instructions for the Pebble 2 watch.


If heat is not a problem and the FDA is overseeing functionality, what are the concerns with wearables? “There’s a lot of interesting discussion about many of the body-sensing applications and whether they are entertainment, sports, or clinical devices. It’s becoming a bigger issue, especially as people get more access to their own health data, because sports/ entertainment devices are not necessarily evaluated rigorously,“ says Lucy Dunne, director of the Wearable Technology Lab at the University of Minnesota. She describes the laboratory as developing innovative smart textiles that are soft, flexible, loose-fitting, and “aesthetically normal“ as compared to everyday clothing. Scientists and engineers understand where variations arise between traditional devices and wearable technologies, Dunne says, because they know “how messy it is to accurately sense something in the wearable environment.“ Consumers on the other hand, see a nice, shiny interface on a device and assume the data it conveys is correct. She explains, “Some of these devices do fall under FDA approval, so they are clinically validated, but the problem in the marketplace is that it’s really hard for the general public to know which is which. And while some of the consumer devices do actually publish their accuracy data, not all of them do.“


The drawback to sports/entertainment devices arises when consumers use the data that devices collect for medical purposes. For instance, people who need to lose 4) ___ for health reasons may look to their devices for accurate estimations of the number of calories they are expending and the number of steps they are walking so that they can manage their diet and exercise. “The technology is so new that we just sort of take data at face value without being too concerned about how they were validated or whether they’re correct,“ Dunne says. “As the power of these devices increases, I think it will become more important to know whether you can trust what a device or interface is telling you.“ Foster counts accuracy concerns as one of the three major issues facing wearable devices. The second on his list is that devices can be distracting, particularly when individuals are doing something that demands their full attention. “I have a smart watch, and every time I get an e-mail, including junk e-mails, my wrist vibrates. I just can’t resist looking at the thing,“ he says. A similar display that continually updates health data would be no different. “I think this is equally as dangerous as texting while driving. It may be just a momentary distraction, but it’s a serious potential problem,“ he says. “Nobody’s really explored the ergonomics of these wearable devices. I see an awful lot of hype in the literature about all of the wonderful things that these technologies are going to do to protect health, but it remains to be seen exactly how useful they are going to be and what the problems are going to be as they get introduced.“ Dunne believes consumers are sometimes mistaken about the accuracy of wearable textiles and devices designed for sports/entertainment purposes. Such smart technology is not required to meet the same high standards as that designed for clinical uses.


A third issue Foster sees is the integration of all of these newly collected data into the 5) ___ care system. He feels it is such an important consideration that he brings up the topic during one of his graduate-level courses. “We talk about apps that detect atrial fibrillation. First of all, the question is: how accurate are these things, given that it’s hard to make high-quality measurements with an app? And then we talk about integration.“ Last semester, Foster and his class heard from a medical doctor who said he’s terrified that he’ll have hundreds of anxious patients constantly sending him data from their apps. He describes the collective potential drain on medical professionals, device-related distractions, and accuracy misunderstandings by users as “serious potential issues that have safety implications and medical-usefulness implications, and these are really big problems.“ More work is definitely needed on integration. Some of this miniaturization that you can wear everyday on your fabrics or on yourself has great potential, and we are very excited about that because it’s now going to give us insights into and more information about the health care process. Concurrently, however, people need to start thinking about the importance and relevance of those data. FDA looks forward to more research into the process and utility of incorporating wearable-collected data into the health care stream. That includes the interoperability of medical devices. This kind of research is going to be very important not just from an FDA safety perspective but also from a health care perspective because (these new technologies) have the potential to bring the whole ecosystem of health care to a better place and change the paradigm of how we look at the 6) ___ body.


Exposure to electromagnetic (EM) radiation has been in and out of the news for decades, as concerns – justified or not – about microwave ovens, then cell phones, and now wearable devices have been aired. When it comes to wearable devices, most scientists, engineers, and health care agencies take the stance that they emit such low levels of EM radiation (typically two orders of magnitude less than a cell phone) that they pose no health risks at all. Some, however, still harbor a cautionary view. “Compared to the medical accuracy issues and the driver safety issues, why worry about a hypothetical risk from some tiny exposures?“ Foster asks. “My smart watch has a low-power Bluetooth transmitter. It’s inconceivable to me that these tiny, 2-milliwatt Bluetooth transmitters are going to cause any exposure problems, particularly when they transmit a small fraction of the time. And besides, everyone in the world is now using cell phones, which may transmit at levels 100 times higher, so the issue of radio-frequency (RF) exposure from relatively much weaker devices is moot.“


Editor’s note: There should be a study that calculates how many devices exist in a given area, like a town or a city. Then another calculation of the amount of RF energies and EM exposures in each area and the effect on all the humans living in that radius. There should be a long term view on this topic, otherwise, we’ll end up with another catastrophic man-made error, like those that have given us Global Climate Change, with all of its ramifications.


People have been looking for hazards associated with RF energies since World War II, when people were worried about RF exposure from military communications systems. Later, they were worried about radiation from cell phones. All along, major health agencies have done comprehensive reviews of the literature and written 1,000-page reviews of thousands of articles and other reviews, and they all say the same thing: they don’t see any clear sign of a problem aside from too much heating, which is already regulated by the FCC.“ It is true that heat is the only universally adopted guideline in health-related exposure regulation, but engineers and researchers should do everything they can to limit EM exposure beyond the mandated limits, says Gert Cauwenberghs, a professor of bioengineering at the University of San Diego Jacobs School of Engineering, codirector of the university’s Institute for Neural Computation, and cofounder and chair of the scientific advisory board for San Diego-based Cognionics, Inc., which is developing wearable technology. “There are studies that have clearly shown other effects of EM fields (EMFs) on body activity,“ Cauwenberghs says. “And if you think about it, this makes perfect sense because radiation doesn’t just get absorbed as heat. Absorption can also have a clear effect on transitions between energy states of 7) ___, such as proteins and DNA, and those transitions could have some life-impacting effects.“ Such transitions can occur even at very low intensities, he asserts, so wearable technologies should be scrutinized. EM radiation can also affect cells from an electrical perspective, Cauwenberghs says, noting that small variations in electrical fields can disrupt the firing of neurons in the brain. “Just a few millivolts of radiation-induced local field potentials are enough to change the activity of neurons,“ he says, adding that EM devices producing intermodulation interference in the 4- to 13-Hz range can directly impact 8) ___ waves. Cauwenberghs readily admits that evidence linking low-level EM radiation and health dangers is less than definitive. “There have been some studies suggesting biological effects of low EM exposure, and not all studies have been rigorously performed – as occurs in every field of study – so there is controversy. However, there are studies that have established some clear effects, and they should be taken seriously,“ he remarks. He points to the Bioinitiative report, which was written by proponents of lowering EM exposure and includes references to some of these studies. “As engineers and scientists, we have to separate the science from the advocacy in this report,“ he says, but he also notes that a number of scientists, particularly from Europe, participated in the report and asserts it has scientific merit. To shed more light on the biological effects of low EM exposure, more research is needed, Cauwenberghs says. That includes theory-guided experiments to understand the bioelectrical mechanisms at play, especially in relation to brain waves.


Regardless of the debate about whether the radiation emitted by wearable sensors and other smart technologies could cause health problems, Cauwenberghs believes engineers and researchers should continually strive to reduce the levels of EM radiation emission and to develop the lowest-powered devices possible. “As engineers, we’re starting to really look into energy efficiency of many systems, but it is slow moving. Even so-called Bluetooth low-energy isn’t what the name implies. What we need is much more energy-efficient technology, and there is still a lot of work that can be done to really improve these wireless systems,“ he says. He describes the typical metric used to measure wireless systems as the energy required to send 1 bit of information a certain distance, and the energy to transmit is proportional to the distance squared. “The best that can be done today is in the lower to upper femtojoule range per bit transmitted over 1 m distance,“ Cauwenberghs says. “If circuit designers can really go after this metric in the same way that processor circuit designers have gone after the femtojoule per multiplier accumulator unit?a measure of how much work a computer does?we can really make some progress and reduce the radiation emitted as well as the footprint of wireless radiation on the environment, which is another important consideration.“ Minimizing the power consumption of wearable devices is desirable, but the primary reason to do so is to prolong battery life. The limit on radiated power depends both on how far the device has to throw a signal to be useful, and the rate at which data must be transmitted. A lot of engineering effort has already been invested in minimizing 9) ___ consumption for the kinds of Bluetooth interfaces that wearable devices typically use, but there is undoubtedly room for further improvement. Irrespective of the reason for the drive to generate low EM and power in smart devices, there will be a push sooner or later to make wearables more efficient, and electrical engineers are able to make a real difference.


Additional work to make technology more efficient will likely always be a goal, but, at this point, studies into health risks of low EM wearable devices simply aren’t necessary, in comparison to studies addressing health concerns about the use of mobile phones and other higher-powered equipment. In an article coauthored with engineer and philanthropist Lorne Trottier, Foster describes the Bioinitiative report as “an egregiously slanted review of health and biological effects of EMFs“ that disregards the fact that, as Foster and Trottier wrote, “the overwhelming majority of scientists see no good evidence for health effects“ at levels below international exposure guidelines, which are similar to FCC safety limits. Because of public concern about cell phone radiation, there have been many studies looking at the effects of cell phone RF signals that are in roughly the same frequency range as Bluetooth and Wi-Fi, and there’s been no clear evidence of any problem,“ Foster says. Since smart devices have transmitters some 100 times less powerful than cell phones, he remarks, “Health agencies say that there are scientific issues regarding RF energy that need to be clarified, in particular the weak connection that has been reported between heavy use of cell phones and brain 10) ___. However, it is ludicrous to worry about possible health risks from the tiny RF exposures from wearables when you read your e-mail on your smart watch while driving.“ (Editor’s note: We hope he meant, in a driverless car!)


As wearable technologies become increasingly popular and begin to make their way into everything from watches to clothing, an increasingly higher percentage of the world’s population will have at least one device -and probably multiple devices – somewhere on their bodies. This presents enormous opportunities and challenges for engineers and other researchers to study the ways people use them, evaluate how their data is or isn’t integrated into medicine, and, ultimately, create the best and safest devices that do the most to improve health care.



1. U. S. Food and Drug Administration. (2015, Feb. 9). Mobile medical applications guidance for industry and Food and Drug Administration staff. [Online].

2. K. R. Foster, “Biological effects of radiofrequency energy as related to health and safety,“ to be published.

3.  K. R. Foster and L. Trottier. (2013, Feb. 15). Picking cherries in science: The Bioinitiative report, science based medicine.[Online].

4. Pulse.embs.org/january-2016/by Leslie Mertz

5. Wikipedia

6. ScienceDaily.com


ANSWERS: 1) devices; 2) blood; 3) radiation; 4) weight; 5) health; 6) human; 7) molecules; 8) brain; 9) power; 10) cancer


Life, Liberty and the Pursuit of Happiness is Good for Your Health


By Machine Elf 1735 – Public Domain: Commons.Wikimedia.org



In 2005 a study conducted by Andrew Steptow and Michael Marmot at University College London, found that happiness is related to biological markers that play an important role in health. The researchers aimed to analyze whether there was any association between well-being and three biological markers: heart rate, cortisol levels, and plasma fibrinogen levels. Interestingly, the participants who rated themselves the least happy had cortisol levels that were 48% higher than those who rated themselves as the most happy. The least happy subjects also had a large plasma fibrinogen response to two stress-inducing tasks: the Stroop test, and tracing a star seen in a mirror image. Repeating their studies three years later Steptow and Marmot found that participants who scored high in positive emotion continued to have lower levels of cortisol and fibrinogen, as well as a lower heart rate. In Happy People Live Longer (2011), Bruno Frey reported that happy people live 14% longer, increasing longevity 7.5 to 10 years and Richard Davidson’s bestseller (2012) The Emotional Life of Your Brain argues that positive emotion and happiness benefit long-term health. Consistent results are that “apart from good health, happy people were more likely to be older, not smoke, have fewer educational qualifications, do strenuous exercise, live with a partner, do religious or group activities and sleep for eight hours a night.“ Happiness does however seem to have a protective impact on immunity. The tendency to experience positive emotions was associated with greater resistance to colds and flu in interventional studies irrespective of other factors such as smoking, drinking, exercise, and sleep.


“Life, Liberty and the pursuit of Happiness“ is a well-known phrase in the United States Declaration of Independence. The phrase gives three examples of the “unalienable rights“ which the Declaration says have been given to all human beings by their Creator, and which governments are created to protect. The United States Declaration of Independence was drafted by Thomas Jefferson, and then edited by the Committee of Five, which consisted of Jefferson, John Adams, Benjamin Franklin, Roger Sherman, and Robert Livingston. It was then further edited and adopted by the Committee of the Whole of the Second Continental Congress on July 4, 1776. The second section of text in the Declaration contains the phrase “Life, Liberty and the pursuit of Happiness“.


We hold these truths to be sacred & undeniable; that all men are created equal & independent, that from that equal creation they derive rights inherent & inalienable, among which are the preservation of life, & liberty, & the pursuit of happiness;


A number of possible sources or inspirations for Jefferson’s use of the phrase in the Declaration of Independence have been identified, although scholars debate the extent to which any one of them actually influenced Jefferson. Jefferson (1743-1826) declared himself an Epicurean during his lifetime: this is a philosophical doctrine that teaches the pursuit of happiness and proposes autarchy, which translates as self-rule, self-sufficiency or freedom. The greatest disagreement comes between those who suggest the phrase was drawn from John Locke (1632-1704) and those who identify some other source.


Editor’s note: After reading about Epicurus (341-270 BCE) and John Locke, and knowing that Jefferson, an avid reader, would have read both philosophies in depth, we feel that he was greatly influenced by both. We are impressed with how long the concept of happiness, has taken to become rooted in human consciousness; and eventually understood to be a human value, that makes life worth living. Achieving a state of happiness, not necessarily constant, requires equal opportunities for all and brings about sustained global peace. Retracing: the concept of happiness was first written about in approximately 290 BCE. This brilliant idea was revived during the Age of Reason in Europe and the Age of Enlightenment in America. Finally, the concept of happiness rose from a philosophy of a few to a political understanding of more, when it became incorporated in the American Constitution, in 1776. In the 21st Century, this idea finally, reached global status when the United Nations, in 2013, declared March 20 as the International Day of Happiness as a way to recognize the importance of happiness in the lives of people around the world. Look how long it’s taken for humans to pass this concept onto a planetary level to be taken seriously; approximately 2,316 years.  Often misunderstood as soft, pursuit of happiness is a value, so serious, it will enable humans around the world to work together on important issues and to reach much needed solutions.


John Locke

In 1689, Locke argued in his Two Treatises of Government that political society existed for the sake of protecting “property“, which he defined as a person’s “life, liberty, and estate“. In “A Letter Concerning Toleration,“ he wrote that the magistrate’s power was limited to preserving a person’s “civil interest“, which he described as “life, liberty, health, and indolency of body (absence of pain); and the possession of outward things“. He declared in his Essay Concerning Human Understanding that “the highest perfection of intellectual nature lies in a careful and constant pursuit of true and solid happiness“. According to those scholars who saw the root of Jefferson’s thought in Locke’s doctrine, Jefferson replaced “estate“ with “the pursuit of happiness“, although this does not mean that Jefferson meant the “pursuit of happiness“ to refer primarily or exclusively to property. Under such an assumption, the Declaration of Independence would declare that government existed primarily for the reasons Locke gave, and some have extended that line of thinking to support a conception of limited government. Benjamin Franklin was in agreement with Thomas Jefferson in downplaying protection of “property“ as a goal of government. It is noted that Franklin found property to be a “creature of society“ and thus, he believed that it should be taxed as a way to finance civil society. If, in reality, “courage and a heart devoted to the good of mankind are the constituents of human felicity, the kindness which is done infers a happiness in the person from whom it proceeds, not in him on whom it is bestowed; and the greatest good which men possessed of fortitude and generosity can procure to their fellow creatures is a participation of this happy character. If this be the good of the individual, it is likewise that of mankind; and virtue no longer imposes a task by which we are obliged to bestow upon others that good from which we ourselves refrain; but supposes, in the highest degree, as possessed by ourselves, that state of felicity which we are required to promote in the world.“


The 17th-century was an enlightened period of history in which some philosophers began promoting that the well-being of our fellow humans is essential to the “pursuit of our own happiness“. William Wollaston’s The Religion of Nature Delineated describes the “truest definition“ of “natural religion“ as being “The pursuit of happiness by the practice of reason and truth“. An English translation of Jean-Jacques Burlamaqui’s Principles of Natural and Politic Law prepared in 1763 extolled the “noble pursuit“ of “true and solid happiness“ in the opening chapter discussing natural rights. Comparable mottos worldwide include “liberte, egalite, fraternite“ (liberty, equality, fraternity) in France; “Einigkeit und Recht und Freiheit“ (unity, justice and liberty) in Germany and “peace, order, and good government“ in Canada. It is also similar to a line in the Canadian Charter of Rights: “life, liberty, security of the person“ (this line was also in the older Canadian Bill of rights, which added “enjoyment of property“ to the list). The phrase can also be found in Chapter III, Article 13 of the 1947 Constitution of Japan, and in President Ho Chi Minh’s 1945 declaration of independence of the Democratic Republic of Vietnam. An alternative phrase “life, liberty, and property“, is found in the Declaration of Colonial Rights, a resolution of the First Continental Congress. The Fifth Amendment and Fourteenth Amendment to the United States Constitution declare that governments cannot deprive any person of “life, liberty, or property“ without due process of law. Also, Article 3 of the Universal Declaration of Human Rights reads, “Everyone has the right to life, liberty, and security of person“.


The World Happiness Report is a landmark survey of the state of global happiness. The first report was published in 2012, the second in 2013, and the third in 2015. The World Happiness Report 2016 Update, which ranks 156 countries by their happiness levels, was released in Rome in advance of UN World Happiness Day, March 20th, 2016. Leading experts across fields of economics, psychology, survey analysis, national statistics, health, public policy and more, describe how measurements of well-being can be used effectively to assess the progress of nations. The reports reviews the state of happiness in the world today and shows how the new science of happiness explains personal and national variations in happiness. This report with its, Happiness Index, reflects a new worldwide demand for more attention to happiness as a criteria for government policy. The widespread interest in the World Happiness Reports, of which this is the fourth, reflects growing global interest in using happiness and subjective well-being, as primary indicators of the quality of human development. Because of this growing interest, many governments, communities and organizations are using happiness data, and the results of subjective well-being research, to enable policies that support better lives.


This year, for the first time, the World Happiness Report gives a special role to the measurement and consequences of inequality in the distribution of well-being among countries and regions. In previous reports the editors have argued that happiness provides a better indicator of human welfare than do income, poverty, education, health and good government measured separately. In a parallel way, they now argue that the inequality of well-being provides a broader measure of inequality. They find that people are happier living in societies where there is less inequality of happiness. They also find that happiness inequality has increased significantly (comparing 2012-2015 to 2005-2011) in most countries, in almost all global regions, and for the population of the world as a whole. The year 2015 was a watershed for humanity, with the adoption of Sustainable Development Goals (SDGs) by heads of state at a special summit at the United Nations in September 2015. Many countries in recent years have achieved economic growth at the cost of sharply rising inequality, entrenched social exclusion, and grave damage to the natural environment. The SDGs are designed to help countries to achieve a more balanced approach, leading to higher levels of well-being for the present and future generations.


Editor’s note: You can be sure that it was stunning to hear, last week, on Bloomberg radio, a discussion about GDP, capitalism, profit, and definitions of American and world values, and the illuminating suggestion that along with all other values, we should add happiness as a highly important bottom line. Along with GDP, reporters are now adding GHP. It’s been a long journey, from 290 BC to 2016, the concept of happiness has traveled from ancient Greece to Bloomberg radio. Time to celebrate!


World Happiness Index’s official site.


Depression in Early Pregnancy Linked to Gestational Diabetes


Gestational diabetes is a form of diabetes (high blood sugar level) occurring only in pregnancy, which if untreated may cause serious health problems for mother and infant. According to a study published online in Diabetologia (19 September 2016), a two-way link has been identified between depression and gestational diabetes.


The authors analyzed pregnancy records from the NICHD Fetal Growth Studies-Singleton Cohort, which tracked the progress of thousands of pregnancies, to understand the patterns of fetal growth. The study enrolled 2,334 non-obese and 468 obese women in weeks eight to 13 of pregnancy. The women responded to questionnaires on symptoms of depression when they enrolled in the study, again between the 16th and 22nd week of pregnancy, and then six weeks after giving birth. The authors also reviewed the women’s records to identify who had developed gestational diabetes.


According to an analysis of pregnancy records, women who reported feeling depressed during the first two trimesters of pregnancy were nearly twice as likely to develop gestational diabetes. Persistent depression from the first to second trimester set women at even greater risk for gestational diabetes, and that women who had the highest scores for depression in the first and second trimesters, about 17%, had nearly triple the risk for gestational diabetes when compared to women who had lower depression scores. Conversely, a separate analysis found that women who developed gestational diabetes were more likely to report postpartum depression six weeks after giving birth, compared to a similar group of women who did not develop gestational diabetes. Although obesity is known to increase the risk for gestational diabetes, interestingly, the likelihood of gestational diabetes was higher for non-obese women reporting depression than for obese women with depression. In fact, depression did not appear to increase the risk for gestational diabetes among obese women. In contrast, non-obese women with high depression scores had nearly triple the risk for gestational diabetes than the other women in the study. The authors added that the results suggest it would be a good idea for clinicians to pay particular attention to women with high depression scores when evaluating the risk of gestational diabetes. The authors also found a higher risk for postpartum depression among the women who had gestational diabetes. Of the women who developed gestational diabetes, nearly 15% experienced depressive symptoms after birth, which was more than four times that of women who had not had gestational diabetes.


Currently, the American College of Obstetricians and Gynecologists recommends that physicians screen patients at least once for depression during the perinatal period (22 weeks of pregnancy through 7 days after birth.)


The authors stressed that the study was not able to prove a cause and effect relationship between symptoms of depression and gestational diabetes, but noted that earlier studies have shown that depression is associated with impaired glucose metabolism that may lead to higher blood sugar levels. Similarly, high blood sugar levels may lead to inflammation, hormonal, and other changes that could lead to symptoms of depression.


Statins Are Associated With Reduced Mortality in Multiple Myeloma


The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) have activity in one of the pathways influenced by nitrogen-containing bisphosphonates, which are associated with improved survival in multiple myeloma (MM). As a result, a study published online in the Journal of Clinical Oncology (19 September 2016) was performed to evaluate the association between statin use and mortality in a large cohort of patients with MM.


For the study, patients were identified from the Veterans Administration Central Cancer Registry who were diagnosed with MM between 1999 and 2013. The authors defined statin use as the presence of any prescription for a statin within 3 months before or any time after MM diagnosis. The authors identified a cohort of 4,957 patients, of whom 2,294 received statin therapy. Results showed that statin use was associated with a 21% decrease in all-cause mortality (P < .001) as well as a 24% decrease in MM-specific mortality (P < .001). This association remained significant across all sensitivity analyses. In addition to reductions in mortality, statin use was associated with a 31% decreased risk of developing a skeletal-related event.


The authors stated that the findings suggest a potential role for statin therapy in patients with MM and that the putative benefit of statin therapy in MM should be corroborated in prospective studies.


Ilaris Approved for Expanded Indications in 3 Rare Diseases


Editor’s Note: Target Health Inc. is very active in the rare/orphan disease area with FDA marketing approvals in Gaucher disease and Cystic Fibrosis. Dr. Jules Mitchel, President of Target Health Inc. will be participating in a panel at the NORD meeting in Washington October 17-18, 2016


The FDA has approved Ilaris (canakinumab) for 3 new indications for the following rare and serious auto-inflammatory diseases in adult and pediatric patients:


Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS);

Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); and

Familial Mediterranean Fever (FMF).


All three syndromes are hereditary diseases that are characterized by periodic attacks of fever and inflammation, as well as severe muscle pain. There are no previously approved therapies for TRAPS or HIDS/MKD.


Ilaris was previously approved for another periodic fever syndrome called Cryopyrin-Associated Periodic Syndromes (CAPS) and for active systemic juvenile idiopathic arthritis. Approvals for the new indications were based on clinical studies, including safety, efficacy and pharmacokinetic data. The most common adverse reactions for these indications are injection site reactions and being more susceptible to catching colds.


Ilaris can cause serious side effects, including increased risk of serious infections as iIlaris can lower the immune system’s ability to fight infections. Other serious side effects include decreased ability to fight infections (immunosuppression) and allergic reactions. Patients experiencing any symptoms of an allergic reaction should call their healthcare provider, including: rash, itching and hives, difficulty breathing or swallowing, and dizziness or feeling faint. Patients should not get live vaccines if receiving Ilaris. Patients should not receive Ilaris if they are allergic to canakinumab or any of the ingredients in Ilaris.


Ilaris is manufactured and distributed by Novartis Pharmaceuticals Corporation, of East Hanover, New Jersey.


Salmon Corn Cakes with Ginger & Dill


It has taken a lot of trial and error, to arrive at this delicious recipe for salmon/corn cakes. And I am happy to share it. The flavors are now, balanced so well, that you get a magnificent mouthful of satisfaction, with the first bite. Not only are these “o-oh so-o“ good, but they are really easy to make, if you take the time to buy all of the ingredients. ©Joyce Hays, Target Health Inc.



A dollop of homemade tartar sauce and you’re in for a real treat. ©Joyce Hays, Target Health Inc.



I made a big batch, but by the end of the weekend they were gone. These salmon/corn cakes are good for dinner, lunch, brunch and snacks. I served them for dinner, Friday night with roasted red, oregano/garlic potato cubes and Brussels sprouts halves, roasted with garlic and aged balsamic vinegar. We started the meal with Hall cabernet sauvignon and cruditees instead of a salad and warm (right out of the oven) home-made corn bread. As you may know, the recipe theme, following Labor Day, has been this season’s superb sweet corn, harvested from local farms. I still have a few more sweet corn recipes, as we enter October. ©Joyce Hays, Target Health Inc.





2 thick salmon fillets (remove any bones and skin)

1 Tablespoon ginger puree

1 Tablespoon lemongrass paste

4 large cloves of garlic, thinly sliced

1 teaspoon turmeric

1/2 cup fresh dill, chopped well

1/2 teaspoon ground coriander

1 teaspoon cardamom

4 fresh ears corn, all kernels scraped off

2 large eggs beaten

2/3 cup fresh cilantro, chopped

1 pinch chili flakes (or cayenne)

1 Tablespoon fish sauce

1 Tablespoon low-sodium soy/tamari sauce

Zest of 1/2 fresh lime

Juice of 1/2 lime

Coconut oil (or ghee) for shallow-frying


Panko to roll the cakes in, before cooking


Get the best fresh ingredients. ©Joyce Hays, Target Health Inc.





Dice one of the salmon fillets, and blend the other to a paste using a food processor. You want to keep some of the salmon in the form of small chunks, to enhance the texture.

Combine all the salmon in a medium bowl. Add the remaining ingredients, and mix well. Marinate this mixture for one hour in the fridge.

You could make rice while you’re waiting and/or a green salad.

When you’re ready to eat, heat the coconut oil in a frying pan. Shape the fish mixture into small patties (I just rolled some into a ball in my hands and then squashed it, slightly, in the pan). But first, roll each salmon/corn cake in the Panko, before cooking.



Rolling the fish cakes in Panko before cooking. ©Joyce Hays, Target Health Inc.



Consider putting a loose (not tight) lid on your pan while the salmon/corn cakes are cooking. Once in a while, you’ll get a corn kernel popping right out of the pan, and you don’t want it to hit you in the eye.



Cook first one side ©Joyce Hays, Target Health Inc.



and then, the other, for about 2 to 3 minutes on each side, depending on how thick your fish cakes are. Lovely smell while cooking. ©Joyce Hays, Target Health Inc.



Fry for a couple of minutes on each side. I bought sushi-grade salmon and cooked it about 2 minutes on each side. If you make your salmon/corn cakes thick, then cook 3 minutes on each side. They should be golden and springy, when done.

Garnish with fresh dill or cilantro. Serve tartar sauce at the table.

Or you could use my previously published whipped white sauce for fish: (it also makes a good veggie dip)

1 container plain Greek yogurt

8 oz. creamy goat cheese (creamy not crumbly), this is optional.

2-3 Polish pickles chopped well

2 large garlic cloves, squeezed

2 Tablespoons Kraft mayo

In a small or medium bowl, whip all of the above ingredients, very well, by hand and serve on the table with the salmon/corn cakes.


Make your favorite rice (boil in chicken broth not water), like jasmine and serve the salmon/corn cakes on top of a mound of rice. You could also serve a fennel pear grape salad, tossed with some toasted sesame seeds, a few flaked almonds and a lemon or lime dressing, garnished with a pinch of fresh coconut shreds. If you serve this in August-October, add fresh figs, cut in quarters.



Naturally, a chilled white wine would be perfect with the salmon/corn cakes; however, if you’re feeling like a red, this Hall cabernet sauvignon is the only red we know of, that goes well with fish. ©Joyce Hays, Target Health Inc.



We were too sad to go out this weekend. The funeral service for one of our most beloved employees, Kuo Ping Yu was on Saturday. Among many, many others, Target Health employees attended. The setting was lovely. His family is especially beautiful, but this occasion was profoundly sad for us.


Farewell, dear KP Yu; you will be greatly missed. You are in our hearts forever.